중앙 임상시험심사위원회 역할과 한계 그리고 극복 방안

Central Institutional Review Board: Past, Present, and Future

  • 이대호 (울산대학교 의과대학 서울아산병원 종양내과)
  • Dae Ho Lee (Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine)
  • 투고 : 2023.09.15
  • 심사 : 2023.09.24
  • 발행 : 2023.09.27

초록

In the conduct of multicenter clinical trials, multiple reviews by multiple Institutional Review Board (IRB) result in unnecessary duplication of efforts, delays and increased expenses of the trials, placing unavoidable burdens on not only investigators and sponsors but also IRBs. During the coronavirus disease 2019 pandemic periods, as the need of multicenter clinical trials for its therapeutics and vaccines increased, a centralized IRB became more important than before in order to efficiently conduct the multicenter trials without unnecessary multiple reviews. Accordingly, government-supported central IBR as a new centralized IRB has launched to foster multicenter clinical trials while to avoid unnecessary reviews and delays and to reduce burdens of all stakeholders. However, there are still barriers to be overcome and problems to be solved in the central IRB. In this review, we introduce background and history of the central IRB and try to propose some strategies or solutions against the barriers and problems.

키워드

참고문헌

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